510(k) clearance
Hemostatic Clip
- 510(k) number
- K261741
- Applicant
- Anrei Medical (Hz) Co., Ltd.
- Decision date
- Oct 2, 2026
- Date received
- May 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PKL
- Device type
- Hemostatic Metal Clip For The Gi Tract
- Device class
- Class II
- Regulation
- 21 CFR 876.4400
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN